In short
Clinical trials are studying Maribavir in transplant patients, including children, adolescents, and young adults. These studies look at safety, effectiveness, and dosing for cytomegalovirus (CMV) and Epstein-Barr virus (EBV) infection. The trials include people after stem cell or solid organ transplant and are in Phase 2, Phase 3, and a phase IV pilot study.
Key points
- Clinical trials are studying Maribavir in transplant patients with viral infections, mainly CMV and EBV. The data include children, adolescents, young adults, and other transplant recipients. The studies are in Phase 2, Phase 3, and a phase IV pilot design, so they are testing both safety and how well the treatment works. One pediatric trial also measures pharmacokinetics to help identify dosing regimens. The main outcomes include viral response, complete viral clearance, and treatment tolerability.
Trial overview
The trial data show three interventional studies of Maribavir in transplant patients with viral infection. These studies focus on cytomegalovirus (CMV) and Epstein-Barr virus (EBV) after transplant. The studies are authorised and include Phase 2, Phase 3, and phase IV research.
Who is being studied
One study includes children and adolescents from 0 years to under 18 years old who have CMV infection after a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT). Another study includes HSCT recipients with CMV infection who cannot take ganciclovir, valganciclovir, or foscarnet because of another medical condition, or who stopped those drugs because of toxicity or intolerance. The third study includes young adult kidney transplant recipients with high recurrent EBV infection.
The transplant setting matters because these patients can have trouble controlling viral infections after treatment that lowers the immune system. In simple terms, the studies are looking at people whose bodies may not fight viruses normally after transplant.
What the trials measure
The pediatric Phase 3 study measures pharmacokinetics (PK), which means how the medicine moves through the body over time. It looks at results such as peak level, time to peak level, lowest level before the next dose, and overall exposure over one dosing interval. It also measures safety and tolerability through serious adverse events, adverse events, vital signs, laboratory tests, ECGs, and stopping the study drug or the study.
The Phase 2 HSCT study measures the percentage of patients whose plasma CMV DNA falls below the lower limit of quantification, confirmed in at least two tests, 8 weeks after treatment starts. It also measures side effects that occur or get worse during treatment and lead to stopping Maribavir. The EBV study measures the proportion of patients who achieve complete viral clearance after Maribavir therapy.
For patients, these are signs that help researchers see whether the virus is getting lower, gone, or still present. They also help show whether the treatment can be continued safely.
Trial phases and study design
The pediatric CMV study is a Phase 3 interventional study with 67 planned participants. Phase 3 studies are usually larger and help confirm both benefit and safety in a defined group. This study also aims to identify dosing regimens for pediatric HSCT and SOT subjects.
The HSCT CMV study is a Phase 2 multicentric interventional study with 81 planned participants. Phase 2 studies often focus on early evidence of effectiveness and safety in a specific patient group. This study looks at Maribavir as first-line therapy in patients who cannot use some standard antiviral drugs, and as second-line therapy in patients who stopped those drugs because of toxicity or intolerance.
The EBV study is described as a phase IV pilot study with 10 young adult SOT recipients. It is a proof-of-concept study, which means it is designed to see whether the idea is promising before larger research is done. The study uses a two-step approach and plans to look at how much EBV can be reduced over time.
Key Maribavir trials in the data
- NCT05319353 studies safety, dosage, and effectiveness of Maribavir in children and adolescents with CMV infection after HSCT or SOT. The main goals are to characterize PK and assess safety and tolerability.
- 2025-521074-34-00 studies Maribavir in HSCT recipients with CMV infection when some standard antiviral drugs cannot be used or were stopped because of toxicity or intolerance. The main goal is to measure treatment response at 8 weeks and safety-related treatment stopping.
- 2025-524786-25-00 studies Maribavir in young adult kidney transplant recipients with high recurrent EBV infection. The main goal is complete viral clearance after therapy.
Patient-friendly terms
Complete viral clearance means the virus is no longer detected in the blood test used in the study. Response to treatment in the CMV study means the virus level drops below the test’s measurable range and this is confirmed in two tests. Safety and tolerability means whether the treatment can be used without side effects forcing patients to stop it.
ECG stands for electrocardiogram, a test that records the heart’s electrical activity. Vital signs are basic checks such as blood pressure, pulse, and temperature. Clinical laboratory evaluations are blood or other tests used to monitor health during the study.